AIDS Research Today: 20 Views.

Twenty commentaries on the current status of AIDS research, by "researchers, clinicians, and community members from varying disciplines, experience and backgrounds" appear in the Summer 2001 issue of CRIA Update, published by the Community Research Initiative on AIDS. These brief summaries offer diverse and informed views of what is happening today in AIDS research -- and what may happen over the next several years.

You can find these summaries at http://www.criany.org, or mail a request to: CRIA, 230 West 38th St., 7th floor, New York, NY 10018 (ask for the AIDS research issue).

Comment on Research

One idea largely missing from these commentaries (including our own) is the possibility of a treatment breakthrough -- and the question of how to organize research to facilitate a major, unexpected advance.

For example, one possible area for such a breakthrough could be a treatment to disrupt the process by which, in most patients, HIV eventually turns off the immune system's original ability to control it well (a possibility discussed in the CRIA Update by Sean R. Hosein of CATIE, the Canadian AIDS Treatment Information Exchange, on excessive levels of IL-b in HIV disease, and the possibility of treatments to lower them). Such an immune-based treatment could work in both developed and developing countries (where it might not need to wait for antiretroviral combinations to become available).

Looking for a breakthrough -- a treatment good enough to be, in effect, approved by acclamation -- means we would not have to wait to solve the problem of immune-based surrogate markers, which will probably take years (and may be essentially unsolvable, if an effective immune-based treatment must first be proven by clinical endpoints before a surrogate marker can be established). In the IL-10 example, a monoclonal antibody to reduce IL- 10 might provide a proof of principle. If it clearly worked (for example, by greatly lowering viral load or reducing the need for antiretrovirals), then it would not be hard to organize a major effort to find simpler or even natural treatments to do so.

The big problem here would be the legal obstacles created by a clinical-trial system designed for big-company drug development. For example, the right kind of trial might be in one patient, looking for an efficacy result even from the first human volunteer, with no attempt to prove efficacy first in animals.

The existing rules serve two purposes -- to protect the public from unethical corporate experimentation, and to protect the same corporations from competition by making it almost impossible for anyone else to finance the whole drug-development process. Of course, if anyone could show truly convincing data, ways could be found to move fast. The problem is getting permission to do the earliest proof-of-principle human studies -- without entanglement in the gold-plated clinical trial system which already has its own mindset, investments, pipeline, and calendar in place, and naturally resists encroachment on its well-manicured turf.

So we continue to fight an epidemic with rules and procedures designed for routine, non-emergency research and development.